DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim limitation “means for applying a compression force” in claim 11 has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder “means” coupled with functional language “applying a compression force” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier.
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim 11 has/have been interpreted to cover magnetic, thermal, sonic, electric force, fluid flow across the micropost array, and impulse forces corresponding to structure described in the specification that achieves the claimed function, and equivalents thereof (Spec., para 0058).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3, 4, 6-9 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Spero et. al. (WO 2018236833 A1) in view of Crivelli et. al. (US 20170152081).
Regarding claim 1, Spero teaches “A modular active surface device comprising:” (Abstract, Modular active surface); “(a) the following layers: (i) a bottom substrate comprising an active surface layer” (Claim 1, a first active surface atop a first active surface substrate;) “(ii) a mask layer on the active surface layer comprising an opening establishing a reaction chamber; and” (Claim 2 and Para [0012], a mask mounted atop the first active surface, wherein the mask defines the area, height, and volume of the reaction chamber. The mask layer of the modular active device comprises an opening for forming the reaction chamber,) “(iii) a top substrate on the mask layer enclosing the reaction chamber,” (Para [0057], Fig 2A and 2B and Claim 3, a second substrate mounted atop the mask, substrate 150).
Spero does not explicitly teach “wherein the top substrate comprises a reagent hopper enclosed therein; wherein the reagent hopper is oriented out of plane with the reaction chamber of the mask layer”.
Crivelli teaches a modular storage and delivery mechanism which includes reaction chambers. In addition to teaching, “wherein the top substrate comprises a reagent hopper enclosed therein; wherein the reagent hopper is oriented out of plane with the reaction chamber of the mask layer”. (Paras [0096] and [0110], Fig 2, number 132 on top substrate out of plane with reaction chamber 114 on a mask layer. [0096] A shell foil 130 is provided atop flow control plate 110 for holding a quantity of liquid, such as reagent (not shown). Namely, shell foil 130 is a flat sheet that includes a blister (or bulb) portion 132 for holding the quantity of liquid. The flow control plate 110 includes two alignment holes 112 for mounting to two alignment pegs 152 of substrate 150. Flow control plate 110 also includes a loading port 114, which is a thru-hole or opening for loading reagent into blister portion 132 of shell foil 130.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Spero to incorporate the teachings of Crivelli wherein the wherein the top substrate comprises a reagent hopper enclosed therein; wherein the reagent hopper is oriented out of plane with the reaction chamber of the mask layer. Doing so separates the reaction area from the reagent storage area which decreases possibly contamination or premature reactions to take place.
Further taught by Spero “(b) a first port in the top substrate providing a fluid path from the reagent hopper into the reaction chamber; and” (Para [0005], [0073], and Fig. 12A and 12B, 112 fluid ports, at least one reaction chamber comprising fluid ports, wherein the fluid ports comprise one or more input ports and one or more output ports.) “(c) a second port in the bottom substrate, the top substrate, or the mask layer providing a fluid path out of the reaction chamber.” (Para [0005] and [0010] and Fig. 2A and 2B, at least one reaction chamber comprising fluid ports, wherein the fluid ports comprise one or more input ports and one or more output ports. The microfluidics cartridge further comprises fluid lines set to correspond to the fluid port, wherein when microfluidics device receives the modular active surface device, the microfluidics device and the modular active surface).
Regarding claim 3, modified Spero teaches all of claim 1 as above in addition to “wherein one or more reagent hoppers each hold a quantity of a dried reagent.” (Para [0012], a dried reagent pellet).
Regarding claim 4, modified Spero teaches all of claim 3 as above in addition to “wherein the dried reagent is selected from a group consisting of a pellet, a cake, a block, a brick, a sphere, or beads of a dried reagent.” (Para [0012], dried reagent pellet).
Regarding claim 6, modified Spero teaches all of claim 1 as above in addition to “wherein the active surface layer comprises actuatable microposts attached to the surface of the active surface layer,” (Para [0057] and [0026], Micropost active surface layer 110 includes an arrangement of microposts 122. FIG. 5A and FIG. 5B illustrate side views of a micropost and show examples of the actuation motion thereof); “wherein the actuatable microposts extend into the reaction chamber.”(Para [0064], Namely, microposts 122 (not visible in FIG. 6) of micropost active surface layer 110 are extending into reaction chamber 105.).
Regarding claim 7, modified Spero teaches all of claim 6 as above. The recitation “wherein the actuatable microposts attached to the surface of the active surface layer are configured for actuation in the presence of an actuation force.” is capability of the actuatable microposts. Spero discloses the positively claimed structural elements of the actuatable microposts as claimed, such actuatable microposts are said to be fully capable of the recited adaption in as much as recited and required herein. In addition, a force is taught within (Para [0039], As used herein, the term "actuation force" refers to the force applied to the microposts. For example, the actuation force may include a magnetic, thermal, sonic, or electric force.).
Regarding claim 8, modified Spero teaches all of claim 7 as above in addition to “wherein the actuation force is selected from a group consisting of a magnetic field, a thermal field, a sonic field, an optical field, an electrical field, and a vibrational field.” (Para [0039], As used herein, the term "actuation force" refers to the force applied to the microposts. For example, the actuation force may include a magnetic, thermal, sonic, or electric force.). Examiner also notes that no element is recited to perform actuation, so actuation is considered an intended use of the device.
Regarding claim 9, modified Spero teaches all of claim 6 as above. The recitation “wherein the active surface layer in the reaction chamber is configured for mixing operations, binding operations, and cell processing operations.” is capability of the active surface layer. Spero discloses the positively claimed structural elements of the active surface layer as claimed, such active surface layer are said to be fully capable of the recited adaption in as much as recited and required herein. However Spero further teaches (Para [0051], micropost active surface in the reaction (or assay) chamber can be used for any purpose, such as, but not limited to, mixing operations, binding operations, cell processing operations (e.g., cell concentration, cell collection, cell filtration, cell washing, cell counting, cell recovery, cell lysis, and cell de-clumping), and the like.)
Regarding claim 14, modified Spero teaches all of claim 1 as above in addition to “wherein (i) the top substrate comprises the mask layer enclosing the reaction chamber and” (Claim 2 and Paras [0012], [0057], Fig 2A and 2B and Claim 3, a second substrate mounted atop the mask, substrate 150, a mask mounted atop the first active surface, wherein the mask defines the area, height, and volume of the reaction chamber. The mask layer of the modular active device comprises an opening for forming the reaction chamber); “(ii) the first port in the top substrate comprises a fluid path from the top substrate into the reaction chamber.” (Para [0005], [0073], and Fig. 12A and 12B, 112 fluid ports, at least one reaction chamber comprising fluid ports, wherein the fluid ports comprise one or more input ports and one or more output ports.).
Claims 2, 5, 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Spero et. al. (WO 2018236833 A1) in view of Crivelli et. al. (US 20170152081) as applied to claim 1 above and in further view of Pollack et. al. (US 8460528 B2).
Regarding claim 2, modified Spero teaches all of claim 1 as above but does not teach “wherein the top substrate on the mask layer comprises two or more reagent hoppers oriented out-of-plane of the reaction chamber.”.
Pollack teaches on-board reagent storage, handling, and dispensing apparatuses and methods for droplet actuator systems in addition to hoppers on the top substrate (Fig. 1A and Column 6 lines 45-60, 134, reservoir within the body (top substrate)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have Spero to incorporate the teachings of Pollack wherein the top substrate comprises a reagent hopper . Doing so would allow the reagent to enter the device to further a reaction. Having a reagent hopper within the top substrate allows the pellets (one or more reagent hoppers) containing the dry reagent within Spero to enter the device in an orientation out-of- plane to a reaction chamber. Pollack teaches a gap 118 within the above column and line numbers. That gap would contain the reaction chamber within Spero. This modification with Spero and Pollack further allows more than one dried reagent to enter the device through the top substrate allows for ease of use the addition of the reagent and having it above the reaction chamber adds another layer of ease of use in the location of the reagent in comparison to the reaction chamber. Having additional reagent hoppers allows for containment of different reagents which stops any premature reactions of the reagents.
Regarding claim 5, modified Spero teaches all of claim 2 as above. Spero does not teach “wherein one or more reagent hoppers each hold a quantity of a rehydrated dried reagent.”.
Pollack teaches “wherein one or more reagent hoppers each hold a quantity of a rehydrated dried reagent.” (Column 6 lines 29-36, FIGS. 1A, 1B, and 1C illustrate side views of a droplet actuator 100. Droplet actuator 100 is designed to permit storage of a concentrated reagent and reconstitution of the concentrated reagent prior to or during use of the droplet actuator.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have Spero to incorporate the teachings of Pollack wherein the reagent hoppers hold a rehydrated dried reagent. Doing so would provide stability of the reagent which would allow the device to shippable with the reagent intact.
Regarding claim 12, modified Spero teaches all of claim 2 as above. Spero further teaches “wherein each reagent hopper contains a reagent selected from a group consisting of a rehydratable dried reagent, a liquid reagent, or a releasable reagent.” (Para [00109], allows a lyophilized pellet).
Regarding claim 13, modified Spero teaches all of claim 12 as above. The recitation “wherein the reagent hoppers contain the same reagent or a different reagent.” is capability of the reagent hoppers. Modified Spero discloses the positively claimed structural elements of the reagent hoppers as claimed, such reagent hoppers are said to be fully capable of the recited adaption in as much as recited and required herein.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Spero et. al. (WO 2018236833 A1) in view of Crivelli et. al. (US 20170152081) as applied to claim 1 above and in further view of Glezer et. al. (US 20050142033 A1).
Regarding claim 10, Spero teaches all of claim 1 as above but does not teach “further comprising an integrated clamping mechanism compressing the layers of the modular active surface device together.”
Glezer teaches modular assay plates in addition to “further comprising an integrated clamping mechanism compressing the layers of the modular active surface device together.” (Para [0137], The plate bottom may be affixed to the plate top by a variety of means, for example, by using adhesives or other bonding agents, conducting or dielectric films, by bonding, fusing or welding the constituent parts, by mechanical fasteners such as clamps.) .
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have Spero to incorporate the teachings of Glezer wherein the device has an integrated claiming mechanism. Doing so would allow the device to and/ or layers to be sealed which provides for a device in which reagents within are more secure and decreases contamination.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Spero et. al. (WO 2018236833 A1) in view of Crivelli et. al. (US 20170152081) as applied to claim 1 above and in further view of Nana et. al. (US 20170268039 A1).
Regarding claim 11, Spero teaches all of claim 1 as above in addition to “further comprising:(a) an active surface substrate comprising an actuatable micropost active surface layer” (Paras [0057] and [0026], Micropost active surface layer 110 includes an arrangement of microposts 122. FIG. 5A and FIG. 5B illustrate side views of a micropost and show examples of the actuation motion thereof); “a microfluidics cartridge substrate” (Para [0010], the modular active surface device is configured to integrate into a microfluidics cartridge that comprises a recessed region configured to receive the modular active surface device. In another embodiment, the microfluidics cartridge further comprises fluid lines set to correspond to the fluid port).
Spero does not teach “and a continuous or a substantially continuous pointed ridge feature provided around the perimeter of a reaction chamber; wherein the pointed ridge feature protrudes from an upper surface of the active surface substrate and toward the actuatable micropost active surface layer; (b) an opposing V-shaped groove feature provided on an inner surface of a microfluidics cartridge substrate, wherein the location, size, and shape of the opposing V- shaped groove feature substantially corresponds to the location, size, and shape of the pointed ridge feature; c) a means for applying a compression force to the pointed ridge feature; wherein, the means for applying a compression force is arranged relative to the pointed ridge feature such that application of a compression force causes the pointed ridge feature to engagedly fit into the opposing V-shaped groove feature of the microfluidics cartridge substrate, thereby forming a seal.”.
Nana teaches reaction vessels and caps. In addition to a groove around a top opening of a reaction chamber taught within the abstract and a plug sized for insertion into a sealing of a reaction chamber of the reaction vessel taught within Para [0023] in addition to teaching ( Para [0023], In addition to mating via the RV plug, the RV and RV cap may include additional features for securely attaching to one another. For example, the RV cap and the RV may be configured such that when the RV cap is inserted into the RV, a ridge of a groove of the RV cap inserts into a groove of the RV, a ridge of a groove of the RV inserts into a groove of the RV cap, or both. In certain aspects, the attachment features secure (e.g., lock, clasp, hook, snap cap, screw cap, and the like) a seal formed between the reaction chamber of the RV and the RV plug of the RV cap. Such securing/locking is particularly useful in the context of containing reaction mixtures subjected to high temperatures (e.g., those subjected to thermocycling for nucleic acid amplification).
The claims require a pointed ridge provided around the perimeter of a reaction chamber and are pointed towards the micropost layer in addition to having opposing V-shaped groove feature on a microfluidic cartridge substrate with a corresponding location which is not exactly taught within Spero or Nana. However Spero teaches to the reaction chamber and microfluidic cartridge and Nan teaches to a reaction vessel, chamber and reaction cap which have ridges, grooves, and a locking mechanism which can take on different forms. Based on this it would have been clearly within the ordinary skills of an artisan before the effective filing date of the claimed invention to have modified the invention of Spero to have a ridge around the reaction chamber to be pointed and to have it in a corresponding location with the microfluidic cartridge V-shaped groove, since Nana teaches a locking mechanism and the layer are securable to each other in addition to such locking of the two layers would be useful when a reaction has a higher temperature. Selecting a pointed ridge and a V-shape groove would be an obvious engineering selection as the two would fit into each other.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have Spero to incorporate the teachings of Nana wherein the applying a compression force to have the pointed ridge engage into the opposing V-shaped groove which forms a seal. Nana teaches a screw cap, clasp and lock would apply a force as a clamp mechanism would which is taught within applicants specifications (Para [00114]). Doing so would provide a seal as taught within Nana which would assist in a reaction of higher temperature which is also taught within Nana.
Response to Amendments
Claim Amendments
Claim amendments have overcome the 112b rejection for claim 14.
Response to Arguments
Applicant's arguments filed 3/23/2026 have been fully considered.
Examiner has withdrawn the prior rejection and made a new rejection based on claim amendments.
Applicant argues Spero does not disclose a reagent "hopper" that is both part of the top substrate and oriented out of plane relative to a reaction chamber. Applicant further argues Pollack fails to cure the deficiencies of Spero as applicant argues that Pollack teaches the reagent storage is coplanar and not out-of-plane.
Examiner has withdrawn the art rejection set for the in the non-final dated 10/21/2025 and made a new rejection which discloses the out-of-plane orientation.
Applicant argues obviousness concerns should be if a person skilled in the art would have made the proposed combinations or modifications and not merely whether they could have made the combinations or modifications.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Examiner has made a new 103 obvious rejections and maintains that reason to modified has been explained within the rejections.
Applicant argues that none of the additional references provide any disclosure as to stacked or modular active surface devices having distinct layers and the incorporation of a top layer having an integrated reagent hopper that is out-of-plane with a reaction chamber.
Applicant’s arguments are found persuasive. Examiner has made a new 103 rejection using additional references.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VELVET E HERON whose telephone number is 571-272-1557. The examiner can normally be reached M-F 8:30am – 4:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached on (571) 270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/V.E.H./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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